Document is current

Article History

Received: 9 February 2025

Accepted: 14 July 2025

First Online: 22 July 2025

Declarations

:

: This trial protocol was reviewed and approved by the Ethics Committee of Dongzhimen Hospital, Beijing University of Chinese Medicine (2023DZMEC492). This clinical trial protocol complies with the relevant provisions of the Declaration of Helsinki and Tokyo for the protection of subjects.Subjects participating in this study will provide written informed consent. During the clinical trial, the personal information of the subject cannot appear in any clinical information.The subject name must be replaced by the number. This trial has purchased insurance for each patient, and if a major serious adverse event occurs during the trial, the insurance company will compensate the patient accordingly.Any modifications to the protocol which may impact on the conduct of the study, patients’potential benefit or safety will require a formal amendment to the protocol. Such amendment will be agreed upon by sponsor and principal investigator, and approved by the Ethics Committee prior to implementation.Version control will use protocol identifiers and dates, as well as a list of amendments, to help track the history of amendments and identify the most recent protocol version.To ensure the impartiality and independence of the project, the Principal Investigator signed the statement of conflict of interest.The informed documents were drafted and distributed to the researchers at medical centers, and the informed documents were modified to meet the local ethical requirements.The participants provided their written informed consent to participate in this trial.The first participant in the FAST trial was randomized on January 9, 2024. By the time of this submission, a total of 298 patients have been enrolled. The full enrollment is expected to conclude by August 2025, with follow-up visits anticipated to be finished by November 2025. The primary results will be disclosed by February 2026.

: Not applicable.

: The authors declare no competing interests.